Gluteal implants and implant systems

ABSTRACT

Gluteal implants and gluteal implant systems are described herein, as are methods of manufacturing and implanting the same. In certain embodiments, the gluteal implant includes a body having a convex upper surface, a concave lower surface, and an edge, the edge being formed by the intersection between the convex upper surface and the concave lower surface. The body can take on various shapes, including a truncated ovoid shape, a truncated approximate ovoid shape, a truncated substantially ovoid shape, a truncated ellipsoid shape, a truncated approximate ellipsoid shape, or a truncated substantially ellipsoid shape, among others. In certain embodiments, the gluteal implant system includes first and second gluteal implants that have the same or different shaped bodies. In certain embodiments, the gluteal implants and gluteal implant systems are implanted in a buttock region.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit under 35 U.S.C. §119(e) of U.S.Provisional Application Nos. 62/109,557, filed Jan. 29, 2015, and62/192,993, filed Jul. 15, 2015, both titled “GLUTEAL IMPLANT SYSTEM FORPREVENTION OF MALROTATION.” The disclosure of each of these priorapplications is hereby incorporated by reference in its entirety herein.

BACKGROUND

Field of the Disclosure

The present disclosure relates generally to implants for augmenting orreconstructing the human body. In particular, the present disclosurerelates to gluteal implants, as well as to gluteal implant systems.

Description of the Related Art

Implants may be used to augment and/or reconstruct the human body.However, current implants are unstable and prone to shifting afterimplantation, which can cause a host of problems for both patients anddoctors alike. For example, among other problems, post-operative shiftscan (1) cause patients pain, discomfort, and embarrassment, (2)necessitate additional doctor intervention (e.g., invasive ornoninvasive), and/or (3) prolong patient recovery times. Accordingly, aneed exists not only for implants and implant systems that prevent,inhibit, conceal, and/or mitigate post-operative shifts that moveimplants and implant systems out of position, but also for implants andimplant systems that alternatively or additionally encourage and/orfacilitate restorative shifts that move implants and implant systemsback into position during and/or following any post-operative shift thatmoves them out of position.

SUMMARY OF SOME EMBODIMENTS

The implants, implant systems, and methods described herein each haveseveral aspects, no single one of which is solely responsible for itsdesirable attributes. Without limiting the scope of this disclosure asexpressed by the claims which follow, some features are describedbriefly below. After considering this description, and particularlyafter reading the section entitled “Detailed Description of SomeEmbodiments,” one will understand the advantageous features of theimplants, implant systems, and methods described herein.

In some embodiments, a gluteal implant can comprise a body comprising aconvex upper surface, a concave lower surface, and a peripheral edge,the edge defined by the intersection between the convex upper surfaceand the concave lower surface. In some embodiments, the body issymmetrical across two orthogonal reference planes and can comprise oneof a truncated ovoid shape, a truncated approximate ovoid shape, atruncated ellipsoid shape, and a truncated approximate ellipsoid shape.In some embodiments, the convex upper surface can comprise one of aportion of a first surface selected from the group consisting of anovoid surface, an approximate ovoid surface, an ellipsoid surface, andan approximate ellipsoid surface, said first surface having a firstsemi-major axis and a first radius of curvature and a first semi-minoraxis and a second radius of curvature. In some embodiments, the concavelower surface can comprise one of a portion of a second surface selectedfrom the group consisting of an ovoid surface, an approximate ovoidsurface, an ellipsoid surface, and an approximate ellipsoid surface,said second surface having a second semi-major axis and a third radiusof curvature and a second semi-minor axis and a fourth radius ofcurvature. In some embodiments, the first radius of curvature differsfrom the third radius of curvature, wherein the difference is betweenabout 2.22 cm and about 2.62 cm. In some embodiments, the second radiusof curvature differs from the fourth radius of curvature, wherein thedifference is between about 2.72 and about 3.12. In some embodiments,the convex upper surface and the concave lower surface intersect at anangle ranging from about 25 degrees to about 39 degrees. In someembodiments, the convex upper surface forms a peak of the implant. Insome embodiments, the concave lower surface forms a peak of a concavity.In some embodiments, the edge forms a bottommost point of the implant.In some embodiments, the edge outlines an oval or ellipse when viewedfrom above.

In some embodiments, a gluteal implant system can comprise a firstgluteal implant and a second gluteal implant. In some embodiments, thefirst and second gluteal implants can have convex curved superior firstand concave second inferior surfaces, the curvature of the first surfacebeing different from the curvature of the second surface. In someembodiments, the first and second gluteal implants can have reflectivesymmetry about exactly two orthogonal planes. In some embodiments, thefirst and second gluteal implants comprise a body having one of atruncated ovoid shape, a truncated approximate ovoid shape, a truncatedellipsoid shape, and a truncated approximate ellipsoid shape.

In some embodiments, a method of implanting a gluteal implant cancomprise preparing a surgical site, forming a cavity in a buttockregion, and implanting a gluteal implant disclosed herein.

Details of one or more embodiments of the subject matter described inthis application are set forth in the accompanying drawings and thedescription below. Any of the features, components, or details of any ofthe arrangements or embodiments disclosed in this application arecombinable and modifiable to form myriad new arrangements andembodiments that fall within the spirit and scope of this disclosure.Other features, aspects, and advantages will also become apparent fromthe description, the drawings, and the claims. Note that the relativedimensions of the following figures may not be drawn to scale.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments will now be described with reference to the followingdrawings, which are provided by way of example, and not by way oflimitation. Like reference numerals indicate identical or functionallysimilar elements.

FIGS. 1A-1C are various perspective views of an implant stabilizingsystem.

FIGS. 2A-2C are various views of the restraining connector of FIG. 1.

FIGS. 3A-3C are various views of the restraining fastener of FIG. 1.

FIGS. 4A-4P are various views of a truncated approximately ovoid implantwith a convex upper surface and a concave lower surface.

FIGS. 5A-5P are various views of a truncated ellipsoid implant with aconvex upper surface and a concave lower surface.

FIGS. 6A-6C show two ellipsoids and a combination thereof, thecombination partly defining the truncated ellipsoid implant illustratedin FIGS. 5A-5P.

FIGS. 7A-7C sequentially illustrate the implant of FIGS. 4A-4P in animplanted equilibrium position, a shifted position, and a restoredequilibrium position.

FIGS. 8A-8O are various views of an infinity shaped implant.

FIGS. 9A and 9B illustrate the cross-sections depicted in FIGS. 4H and4K to further illustrate the type of two dimensional shape formed at thecross-section.

FIGS. 10A and 10B illustrate the cross-sections depicted in FIGS. 5H and5K to further illustrate the type of two dimensional shape formed at thecross-section.

FIG. 11 is a top perspective view of the implant of FIGS. 4A-4P.

FIG. 12 is a bottom perspective view of the implant of FIGS. 4A-4P.

FIG. 13 is a front view of the implant of FIGS. 4A-4P.

FIG. 14 is a rear view of the implant of FIGS. 4A-4P.

FIG. 15 is a left side view of the implant of FIGS. 4A-4P.

FIG. 16 is a right side view of the implant of FIGS. 4A-4P.

FIG. 17 is a top plan view of the implant of FIGS. 4A-4P.

FIG. 18 is a bottom plan view of the implant of FIGS. 4A-4P.

DETAILED DESCRIPTION OF SOME EMBODIMENTS

Embodiments of the present disclosure provide implants and implantsystems for human bodies. In particular, the present disclosure relatesto implants and implant systems which prevent, inhibit, conceal, and/ormitigate post-operative shifts (also referred to as post-operativemovement) that move implants and implant systems out of position, aswell as to implants and implant systems that alternatively oradditionally encourage and/or facilitate restorative shifts that moveimplants and implant systems back into position during and/or followingany post-operative shift that moves them out of position. For example,in some aspects, implants and implant systems are described whichprevent, inhibit, conceal, and/or mitigate post-operative mal-rotationand/or mal-translation events, and in some aspects, implants and implantsystems are described which alternatively or additionally encourageand/or facilitate restorative movements which bring implants and implantsystems back into position during and/or following post-operativemal-rotation and/or mal-translation events.

In some aspects, implants that are restrained relative to one anotherare described, and in some aspects, implants that are unrestrainedrelative to one another are described. Specifically, in certainembodiments, implants and implant systems are described which includestabilizing features that link two or more implants together and/or thatanchor one or more of the implants to the surrounding tissue, and incertain embodiments, implants and implant systems are described which donot include stabilizing features that link two or more implants togetherand/or that do not include stabilizing features that anchor one or moreof the implants to the surrounding tissue. Further, in certainembodiments, implants and implant systems are described which areconfigured to positionally self-correct back into position,facilitatively and/or automatically, when moved out of position (e.g.,automatically translate and/or rotate back into position after havingbeen moved out of position). While certain embodiments are describedbelow, these embodiments are presented by way of example only, and canbe embodied in myriad ways.

Implants are generally described as being one of two main shapes:non-round (e.g., teardrop, ovoid, spheroid, oval, ellipse or disk),which are asymmetrical except about one or two planes or axes ofsymmetry, and round (e.g., circle, sphere, or hemisphere), which aresymmetrical about an infinite number of planes or axes. However, itshould be appreciated that many non-round conventional implants that aredescribed with modifiers that connote reflective symmetry across twoplanes of symmetry actually do not have any plane of symmetry (e.g.,“ovoid,” “ellipsoid,” and “teardrop”) because rather than describing thethree-dimensional shape of the implant, such modifiers are often used todescribe the two-dimensional shape of the implant's projected perimeteronto a frontal plane when viewed from above. It should also beappreciated that ovals, ellipses, and circles are two-dimensional shapesand that ovoids, ellipsoids, spheres, and spheroids arethree-dimensional shapes.

Non-round and round implant shapes function similarly in some cases butproduce different aesthetic results and carry different degrees ofpost-operative movement risk. Aesthetically, non-round implants can insome cases create more naturally appearing anatomical curves than roundimplants. However, with respect to risk, non-round implants have agreater chance than round implants of post-operatively shifting out ofposition. Thus, while non-round implants can advantageously providepatients with a higher level of aesthetic satisfaction, they can alsolead to more post-operative complications since they are less stable.

The higher risk of post-operative movement that is associated withnon-round implants can be a product of myriad factors, including: (1)non-round implants having too much symmetry (e.g., ovoid implants aresymmetrical about three planes of symmetry) and (2) conventionalnon-round implants are unrestrained relative to one another. As a resultof either of these factors, ovoid buttock implants, for example, havebeen said to carry a greater chance of post-operatively mal-translatingand at least a 50% or more incidence of post-operatively mal-rotating(mal-translating and mal-rotating are also separately and/orcollectively referred to as shifting and post-operative movement). Asused herein, mal-translation is the undesired gradual or suddentranslation (e.g., straight and/or curved planar movement) of animplanted implant, and mal-rotation is the undesired gradual or suddenrotation (e.g., clockwise or counterclockwise movement relative to afrontal plane) of an implanted implant. It should be appreciated thatmal-translation and mal-rotation can occur separately or together.

When an implant mal-translates and/or mal-rotates, it can cause patientsa number of problems, including pain, discomfort, and a change inphysical appearance, among others. For example, anatomically incorrector unpleasing aesthetics can form in the buttock region as a result ofpost-operative shifts. Since implants are not designed to move back intoposition following a post-operative shift, doctors typically need toperform some sort of corrective action to bring the implant back intoposition.

The corrective action used will depend on the severity of thepost-operative shift, such as, for example, whether it is mild,moderate, or severe, among others. Generally, such action may includeprescribing additional pain medication for mild post-operative movement,manually manipulating (e.g., de-rotating and/or de-translating) theimplant for moderate post-operative movement, or surgically adjusting(e.g., de-rotating and/or de-translating) the implant for severepost-operative movement. However, manual manipulation and surgicalcorrection can not only cause the patient to experience additional painand discomfort on top of the pain and discomfort already caused by theimplant shifting out of position, such methods can also prolong thepatient's recovery time by additionally traumatizing the implant region.Patients may also develop secondary medical conditions that need to betreated, which can complicate the recovery process even more. Forexample, mal-translation and/or mal-rotation events can cause patientsto feel unhappy about their body image to the extent that their mentalhealth is put in jeopardy (e.g., depression, anxiety, etc.), and untilthe post-operative shift is effectively managed or corrected, suchsecondary medical conditions might also need to be treated.

To summarize, post-operative movements can cause problems for doctorsand patients alike. Specifically, post-operative movements caninconvenience patients by causing them unexpected discomfort, prolongedrecovery times, and a host of secondary conditions. Similarly,post-operative movements can inconvenience doctors by causing them todevote additional time, money, and resources to correct implantationsthat were properly implanted to begin with. Further, post-operativemal-translations and/or mal-rotations, as well as the problemsassociated therewith, may manifest at any time, both in the short andlong term. Thus, while non-round implants can produce better aestheticresults than round implants, they nevertheless have a greater chance ofcausing the aforementioned problems than round implants since non-roundimplants have a higher chance of shifting out of position.

As a result, patients currently face a binary decision when choosingimplants: either (1) choose an implant with better aesthetic properties,or (2) choose an implant with better stability. That is, while non-roundimplants may be more aesthetically pleasing, they nevertheless have agreater tendency to shift out of position relative to their roundcounterparts, and while round implants may be less aestheticallypleasing, they nevertheless have a lesser tendency to shift out ofposition relative to their non-round counterparts. Thus, a need existsfor non-round implants that are more stable and/or for non-roundimplants that can more easily move back into position. Specifically, aneed exists for implants and implant systems which prevent, inhibit,conceal, and/or mitigate post-operative shifts, as well as for implantsand implant systems that alternatively or additionally encourage and/orfacilitate restorative shifts that move implants and implant systemsback into position during and/or following any post-operative shift thatmoves them out of position.

In certain embodiments, the instability associated with current implantsis solved and/or improved by restraining one or more implants relativeto one another and/or relative to one or more stabilizing features(e.g., a restraining connector). For example, in certain embodiments,two or more implants (e.g., ellipsoid, sphere, or spheroid implantshaving ellipse shaped perimeter projections onto a frontal plane) arerestrained relative to one another by connecting at least two of themtogether with one or more stabilizing features, and in certainembodiments, each implant is alternatively or additionally restrainedrelative to itself with one or more stabilizing features (e.g.,restraining connectors and/or tissue anchors). In certain embodiments,one or more of these connections and/or stabilizing features areconfigured to stabilize implants in a way that prevents, inhibits,conceals, and/or mitigates post-operative shifts. As a result, many ofthe post-operative movement complications associated with non-roundimplants can be reduced or eliminated, thereby saving both patients anddoctors from the inconveniences and problems discussed above.

Turning to FIG. 1A, FIG. 1A illustrates an implant mal-rotation and/ormal-translation stabilizing system 100, such as, for example, a glutealimplant stabilizing system. As illustrated in FIG. 1A, the stabilizingsystem 100 comprises multiple components intended to be assembledtogether. For example, in the illustrated embodiment, the stabilizingsystem comprises a plurality of implants 105 configured for a left andright buttock, at least one restraining connector 400 configured forsecure attachment to the plurality of implants 105, and a plurality ofrestraining fasteners 700 to secure the at least one restrainingconnector 400 to the plurality of implants 105. In certain embodiments,the stabilizing systems described herein (e.g., stabilizing system 100)allow a first implant to be tethered (also referred to as linked,coupled, attached, leashed, etc.) to a second implant and/or to thehuman body. For example, in certain embodiments, the stabilizing system100 links two or more implants together such that each of the two ormore implants is physically coupled to one or more other implants.

In certain embodiments, the plurality of implants 105 comprises a rightgluteal implant 200 and a left gluteal implant 300 configured to receivea portion of one or more restraining connectors 400 and one or morerestraining fasteners 700. However, it should be appreciated that leftand right breast implants are also appreciated, as well as implants forany other anatomical location. It should also be appreciated that theplurality of implants 105 can comprise any suitable number of implants,such as, for example, one, two, three, four, or more implants, amongothers.

In certain embodiments, the restraining connector 400 can include anadjustable or fixed central elongate member 410 (similar to a leashstructure) with one, two, or more removable lateral rings 420 attachedto or proximate each terminal end. In certain embodiments, thestabilizing system 100 can include more or less components. For example,in certain embodiments, the stabilizing system 100 is manufactured as aunitary system by, for example, a molding or co-molding process. Asanother example, in certain embodiments, the stabilizing system 100 caninclude two or more restraining connectors 400. However, any suitablenumber of components and features which restrain two or more implantstogether is appreciated.

As further shown in FIG. 1A, a surface of each of the plurality ofimplants 105 comprises one or more surface features, such as depressions800 configured for receiving one or more restraining connectors 400 andone or more restraining fasteners 700. The surface depressions 800 caninclude one or more medial restraining grooves 500 and one or moreassociated pairs of medial apertures 600. The restraining grooves 500are configured to receive a portion of the central elongate restrainingmember 410 and the apertures 600 are designed to accommodate a lateralring 420 and a restraining fastener 700. In certain embodiments, theplurality of restraining grooves 500 each terminate with at least oneterminal aperture 600, wherein each aperture 600 further comprises asurface cavity 610 and an interior cavity 620. In some embodiments, thesurface cavity 610 can have a diameter that is larger than that of theinterior cavity 620. The surface cavity 610 is configured to receive alateral ring 420 and also house a portion of a restraining fastener 700.The interior cavity 620 is configured to receive a portion of arestraining fastener 700. Other aperture designs and housingaccommodations are also appreciated, for example, in some embodiments,the cavities and rings need not necessarily be circular in shape, andcan be square, triangular, oval, or any other suitable shape. Moreover,in some embodiments, it is appreciated that the surface features neednot necessarily be part of a shell of the implant per se, but are partof a housing/casing sized and configured to hold an implant within acavity of the housing, akin to a pillowcase.

FIG. 1A also illustrates that the restraining connector 400 isconfigured to connect the plurality of implants 105. The restrainingconnector 400 is sized and shaped so that a restraining groove 500 and acavity 600 or a pair of complementary cavities 600 can receive it. Tosecure the restraining connector 400 to an implant, restrainingfasteners 700 are used to anchor (also referred to as fasten) therestraining connector 400 to one or more cavities 600 on each of theplurality of implants 105. Anchoring is accomplished by pushing, orotherwise moving a fastener 700 through a fastener hole 430 of a lateralring 420 into an aperture 600 on one or more of the plurality ofimplants 105. Other anchoring mechanisms such as snap-fit components,threaded screws, zip ties, and the like can also be utilized, and forwhich the surface features of the implant (e.g., depressions 800) can beadapted to accommodate. Such anchoring mechanisms can be designed toprevent the restraining connector from detaching from an implantpost-operation.

The restraining connector 400 secures the plurality of implants 105relative to one another, which can reduce or prevent post-operativemal-rotation and/or mal-translation of the plurality of implants 105.This is because the restraining connector restrains and/or resistsunwanted motion, and in some cases can be configured to exert tension onthe implants 105. As discussed above, post-operative implant movementcan occur during the healing process or at any time post-recovery. Suchmovement can include mal-translation, mal-rotation, or some combinationthereof. Without a restraining connector 400, such post-operativeshifting is opposed only by the internal resistive forces exerted by thehuman body against each implant at and/or proximal the respectiveimplant site. Thus, depending on the magnitude of the countervailingforces subjecting the implant to translation and/or rotation, suchtranslation or rotation may be minimally opposed if a restrainingconnector (e.g., restraining connector 400) is not utilized to tetherthe plurality of implants together. By contrast, restraining connectors(e.g., restraining connector 400) link implants together to create acombined implant that has a larger size, shape, and mass that betterresists post-operative translational and/or rotational movement of oneor more of the tethered implants. That is, with the restrainingconnector, post-operative movement is reduced or eliminated because theplurality of implants 105 can no longer move independently without alsocommunicating some fraction of that movement to one or more of the otherimplants and to one or more other parts of the human body. In this way,mal-rotational and/or mal-translational forces experienced by an implantare resisted by another implant and the surrounding tissue structure andvice versa. Further, in certain embodiments, the stabilizing system 100can be implanted such that the restraining connector applies apost-operative force (e.g., a preload) on the plurality of implantsdesigned to counteract post-operative movement, such as, for example,typical rotation events. For example, in certain embodiments, therestraining connector is optionally configured and implanted to apply apost-operative tension and/or compression between and/or among one ormore implants in any suitable direction(s). In such embodiments, therestraining connector may likewise reduce and/or eliminatepost-operative movement.

The implant stabilizing system 100 illustrated in FIG. 1A is alsooptionally adjustable. For example, in certain embodiments, thestabilizing system 100 is adjustable in a variety of directions, suchas, for example, within a plane defined by two orthogonal referenceaxes. In some embodiments, the one, two, or more restraining grooves 500are generally oriented in a medial-lateral direction and spaced apart ina superior-inferior direction, although it should be appreciated thatthe grooves can also and/or instead be oriented and/or spaced apart inany suitable fashion, such as, for example, diagonally. In certainembodiments, the restraining grooves 500 can comprise a first top groove510, a second middle groove 520, and a third bottom groove 530, as wellas associated apertures 600. In certain embodiments, one, two, three, ormore apertures 600 are associated with each groove on each implantsurface. However, it should be appreciated that any suitable number ofgrooves and any suitable number of apertures are envisioned. Forexample, in some embodiments, one or more grooves without an apertureare utilized. It should also be appreciated that different grooves canhave different relative orientations and different numbers of aperturesassociated therewith. For example, in some embodiments, the implantsurface includes more or less than three grooves, and in someembodiments, each groove terminates with more or less than threeassociated apertures, such as, for example, one, two, four, five, ormore grooves, and/or one, two, four, five, or more associated apertures.To illustrate, just as the restraining connector has one or more lateralrings 420 at each terminal end, the one or more restraining grooves 500may likewise have one or more apertures 600 at their correspondingterminal ends. Advantageously, a plurality of restraining grooves andapertures on the implant provides a physician with multiple site optionsand multiple anchor points for the restraining connector, thereby betterenabling the doctor to optimize both the positioning and anchoring ofthe implant stabilizing system. As shown in FIG. 1A, the multiplerestraining grooves and apertures allow a doctor to customize theimplant stabilizing system 100 according to each patient's physiologicalneeds and/or personal desires.

In modifying the implant stabilizing system 100 for a particularpatient, a doctor can make adjustments to the restraining connector 400itself. For example, in some embodiments, the central elongate member410 is non-adjustable and terminates at each end with one or moreremovable lateral rings 420 and fastener holes 430. By removing one ormore lateral rings 420, the length of the restraining connector 400, andtherefore the distance (also referred to as a gap) between the pluralityof implants 105, can be adjusted. Removal can be accomplished by cuttingor snapping the ring from the connector or via some other removalmethod. In some embodiments, the lateral rings 420 not utilized forfastening do not need to be removed, and thus can be preserved forpost-operative adjustment if necessary. In other embodiments, thecentral elongate member 410 is an adjustable member that can lock intoplace. For example, the central elongate member 410 can be extendible,compressible, rotatable, or any suitable combination thereof. Theseadjustments similarly allow the gap between the plurality of implants105 to be modified. In addition, the rotational aspect of the centralelongate member 410 also allows the plurality of implants 105 to sit indifferent planes from one another, which may or may not be necessarydepending on patient physiology. It should be appreciated that theadjustable segment of the central elongate member 410 can include anyportion thereof and can be realized in any suitable fashion. In someembodiments, the central elongate member can include one or moreremovable lateral rings 420 as well as an adjustable central elongatemember 410 that can lock into place. In some embodiments, the centralelongate member 410 can include one or more lockable hinges to adjustthe angle between the plurality of implants 105.

Having the capability to adjust the implant stabilizing system 100 canbe important since it can make it easier to accommodate the physical andmental health needs of more people. For example, depending on thepatient, myriad factors and/or events may combine to cause or createphysical imperfections and/or mental health issues. For example, apatient may have undergone severe trauma to the implant region, apatient may have experienced excessive gluteal weight gain through poordiet and exercise habits, a person may have been the victim ofuncontrollable outside stressors which lead to excessive weight loss anda resulting decrease in buttock mass, a patient may have been born witha congenital buttock defect, a patient may have had a mastectomy, apatient may have received an unrestrained implant system which laterrotated or translated out of position, or a patient might be unhappywith their body image.

As described above, and as shown in FIG. 1A, the plurality of implants105, the restraining connector 400, and the one or more restrainingfasteners may be separate components, and can be composed of anysuitable biocompatible material such as silicone and/or plastic, amongothers. In certain embodiments, the stabilizing system 100 ismanufactured from, for example, silicone or silicone reinforced with amaterial such as Dacron. However, other materials and combinations arealso envisioned. For example, in some embodiments, the connector 400 andthe restraining fasteners 700 are combined into a single element.Further, in some embodiments, the implant shape is round or non-round(e.g., oval), or any other customizable shape that facilitates buttockaugmentation and/or reconstruction, including implant geometriesdescribed elsewhere herein. For example, in FIG. 1A, the implants areovoid shaped. In some embodiments the plurality of implants 105 havedifferent shapes relative to one another, and in some embodiments, theyare the same shape relative to one another.

FIGS. 1B and 1C illustrate variations of the embodiment depicted in FIG.1A. For example, FIG. 1B illustrates an implant restraining system 100having a plurality of apertures 600 positioned adjacent one another. Forexample, FIG. 1B illustrates three apertures adjacently positioned suchthat one, two, or three rings 420 can be inserted into the implant toadjust the width between the implants 200, 300. In certain embodiments,the width between the implants 200, 300 can be adjusted by removing oneor more rings 420 from the restraining connector 400 and positioning therestraining connector in the desired surface depressions. In certainembodiments, no rings are removed prior to implantation. FIG. 1Cillustrates an implant restraining system 100 without the grooves 510,520, 530. In such embodiments, the width between the implants 200, 300can be adjusted by removing one or more rings 420 from the restrainingconnector 400 and positioning the restraining connector in the desiredsurface depressions. In certain embodiments, no rings are removed priorto implantation.

FIGS. 2A-2C illustrate various views of the restraining connector 400 ofthe implant stabilizing system 100 illustrated in FIG. 1A. Specifically,FIG. 2A illustrates a front view of the restraining connector 400, FIG.2B illustrates a top view of the restraining connector 400, and FIG. 2Cillustrates a side view of the restraining connector 400. As discussedabove, the restraining connector 400 is designed to link two or moreimplants together. This link is part of what reduces or preventspost-operative movement. As shown in FIG. 2A, the central elongatemember 410, which is optionally fixed or adjustable, has one or morelateral rings 420 at each end. A fastener hole 430 is located throughthe center of each lateral ring 420. In addition, each ring, other thanthe two lateral rings 430 that are adjacent to the central elongatemember 410, can be removed at their corresponding separation points 440.In some embodiments, the restraining connector 400 does not have anylateral rings 430 and is instead only an elongate bar with a straightand/or curved form that can be snapped or pushed into place. As furtherillustrated in FIG. 2A, the restraining connector 400 has a shape thatmirrors the shape and orientation of the surface depressions 800 shownin FIG. 1A. In this case, the restraining connector 400 outlines an arcof an imaginary circle, but other shapes and orientations are alsopossible (e.g., straight or zig-zagged).

FIGS. 3A-3C illustrate various views of the restraining fastener 700 ofFIG. 1A. Specifically, FIG. 3A illustrates a front view of therestraining fastener 700, FIG. 3B illustrates a top view of therestraining fastener 700, and FIG. 3C illustrates a perspective view ofthe restraining fastener 700. As shown in FIG. 3A, the restrainingfastener 700 has a fastener top 710, a fastener ring 720, a fastenercenter 730, and a fastener tip 740. The fastener 700 is configured tosecure one or more restraining connectors to a plurality of implants(see also FIGS. 1-2). Accordingly, the fastener 700 has a shape thatfits through a lateral ring hole 430 and into an aperture 600 shown inFIG. 1A. In some embodiments, the fastener tip 740 and fastener center730 fit into an interior cavity 620 by passing through a lateral ringhole that is positioned in a surface cavity 610. In some embodiments,the fastener tip 740 and fastener center 730 are first pushed through alateral ring hole and then later pushed into an aperture 600. Once thefastener tip and center are through the ring, the fastener may “snap”into place, wherein the fastener ring 730 occupies the lateral ring holein the surface cavity 610 and the fastener top covers the lateral ring420 and ring hole 430 in or above the surface cavity 610. To passthrough the lateral ring hole, the fastener should be made out of amaterial that is deformable but firm. For example, in some embodiments,the fastener is made from silicone reinforced with Dacron, however, anysuitable material is appreciated. The fastener 700 can secure therestraining connector 400 to the implant such that the restrainingconnector does not become detached from any groove or aperturepost-operation. The elongate member 410 can be either elastic ornonelastic in some embodiments. In some embodiments, the elongate member410 can include one or more adjustment mechanisms, such as a spool,ratchet, or the like to adjust the distance between the first implantand the second implant postoperatively without necessarily requiringdetachment of the elongate member 410 from the first implant and/or thesecond implant.

In certain embodiments, restrained and/or unrestrained implant systemscan be used to help solve the problem of post-operative implantmovement. In both types of systems, the implants can be any shape andhave any surface that is symmetrical about two planes (e.g., twoorthogonal planes). Some examples of implant shapes with symmetry aboutacross two planes include shapes that are ellipsoids, approximateellipsoids, substantially ellipsoidal, ovoids, approximate ovoids,substantially ovoidal, spheres, approximate spheres, substantiallyspherical, spheroids, approximate spheroids, substantially spheroidal,teardropoids, approximate teardropoids, substantially teardropoidal,paraboloids, approximate paraboloids, substantially paraboloidal,polygonoids, approximate polygonoids, or substantially polygonoidal, andtruncations thereof, among any other suitable shape having curved and/orangular surfaces, including shapes with parametric and/or non-parametricsurfaces. For unrestrained implant systems, the implant can be sized andshaped to have rotational symmetry about a center axis. The symmetry ofthe implant functions to conceal, or otherwise mitigate, the effects ofpost-operative movement. For example, in some embodiments, the implantcan conceal mal-rotation events that rotate the implant 180 degrees orapproximately 180 degrees (e.g., clockwise or counterclockwise) becausethe implant still has same aesthetic appearance at the implant siteafter the 180 degree or approximate 180 degree rotation. This is incontrast to conventional implants, which are, for example, tear-dropshaped and cannot be rotated 180 degrees and still have the sameaesthetic appearance at the implant site. The implant geometries asnoted herein can refer to the unconstrained natural implant shape,and/or their shape when implanted in the body in some embodiments.

For example, FIGS. 4A-4P and 5A-5P illustrate various views of twoimplant shapes that have exactly two planes of reflective symmetry, andwhich are designed so that they can be rotated a desired amount, such as180 degrees after implantation and not have the newly rotated positionaffect the aesthetics of the implant site. Specifically, FIGS. 4A-4Pillustrate various views of an exemplary truncated approximately ovoidimplant 10 with a convex upper surface and a concave lower surface, andFIGS. 5A-5P illustrate various views of an exemplary truncated ellipsoidimplant 10′ (also referred to as a truncated ovoid) with a convex uppersurface and a concave lower surface. While not a perfect truncated ovoidin a strict geometrical sense, the implant 10 in FIGS. 4A-4Pnevertheless closely resembles a truncated ovoid and is thereforereferred to as a truncated approximately ovoid implant. In certainembodiments, the implants shown and described herein are formed from asection of one or more three dimensional bodies and/or surfaces. Likereference numerals between FIGS. 4A-4P and 5A-5P indicate the same orsimilar features having the same or similar properties. Thus, unlessotherwise noted, reference numerals in FIGS. 5A-5P refer to featuresthat are the same as or generally similar to the features of FIGS. 4A-4P(e.g., the implants 10, 10′ have different surface curvatures).

With reference to FIGS. 4A-4P, the implant 10 can be used in anyanatomical location, such as, for example, the chest, the face, theupper and lower extremities, and the buttocks, among others. Asdescribed above, the implant 10 can be configured to have rotationalsymmetry that conceals the effects of post-operative movement orsuboptimal implantation technique, such as, for example, post-operativemovement involving a 180 degree or approximately 180 degree shift abouta center axis. These positions of rotational symmetry can correspond topositions of stability (also referred to as equilibrium positions). Incertain embodiments, the implant can be sized and shaped so that it hastwo or more positions of stability, or only one position of stability.For example, the implant 10 can be configured to have a size and shapethat is stable in one, two, or three equilibrium positions, among anyother suitable number, the positions of stability being separated by anysuitable angle, such as, for example, 180 degrees or approximately 180degrees, 90 degrees or approximately 90 degrees, 45 degrees orapproximately 45 degrees, among others. As used herein, equilibriumpositions refer to anatomically natural, desired, and/or acceptableimplant positions. In certain embodiments, the implant 10 is configuredto resist/encourage movement away/toward the implant's equilibriumposition(s).

In certain embodiments, the implant 10 is part of an implant system oftwo or more implants, such as, for example, a restrained or unrestrainedimplant system. For example, in certain embodiments, in addition tobeing adapted so that its size and shape helps stabilize it in one ormore equilibrium positions, the implant 10 additionally includes and/oris coupled to one or more stabilizing features (e.g., a restrainingconnector and/or tissue anchor) as described above with reference toFIGS. 1-3C. However, in other embodiments, the implant 10 does notinclude a stabilizing feature and is not connected to another implant,but is instead stabilized with its size and shape alone, in addition toany interaction it has with the human body.

In certain embodiments, the implant 10 is configured to positionallyself-correct back into an equilibrium position after having been movedout of that or a different equilibrium position, either facilitativelyor automatically. For example, in certain embodiments, the implant 10automatically translates and/or rotates back into an equilibriumposition following a post-operative shift. Similarly, in certainembodiments, the implant 10 facilitates the manual translation and/orrotation of itself back into an equilibrium position. For example, incertain embodiments, an external source can “nudge” or apply a force oflonger duration to the implant so that it moves back into an equilibriumposition. In certain embodiments, the external source need only providean initial nudge, after which the implant 10 auto-translates and/orauto-rotates back into a position of stability. In other embodiments,the external source can apply a continuous or varying force against theimplant to manually translate and/or rotate it back into an equilibriumposition, during which the implant 10 can facilitate such manualmanipulation by being predisposed to return to a position of stability.

For example, in certain embodiments, after the implant 10 has beenimplanted, it is predisposed or otherwise inclined, at least partlybecause of its shape and/or size (1) to remain in its equilibriumposition, (2) to resist any departure therefrom, and (3) to return tothe same or to a different equilibrium position if a disruptive forcecauses a post-operative shift that moves it out of position. Forexample, as discussed above, the implant 10 is sized and shaped toencourage and/or facilitate restorative movements that bring the implantback into one of its equilibrium positions during and/or following apost-operative mal-rotation and/or mal-translation event. In suchembodiments, when a post-operative shift occurs, the implant 10 is orcan be subjected to restorative forces directed toward an equilibriumposition that moves the implant 10 back into a position of stability.

The restorative forces can originate internally and/or externallyrelative to a person's body. For example, internal restoring forces canoriginate from surrounding tissue, from surrounding body structure, fromthe size and shape of the implant 10 itself, and/or from interactionsbetween the implant 10 and the surrounding body (e.g., the implantcavity), and external restoring forces can originate from sources suchas, for example, a person's hand, a chair, an electromagnetic force, orany suitable object or device. In certain embodiments, the internalrestorative forces that develop in the implant region in response topost-operative shifts are alone sufficient to automatically move theimplant 10 back into an equilibrium position, i.e., the implant 10automatically self-corrects. In other embodiments, the internalrestorative forces are aided by an external restorative force thattogether move the implant 10 back into an equilibrium position, i.e.,the implant 10 facilitatively self-corrects in the sense that the sizeand shape of the implant makes it easier to return the implant 10 to anequilibrium position with outside help.

With reference to FIGS. 4A-4E, FIG. 4A illustrates a top elevationalview, FIG. 4B illustrates a top perspective view, FIG. 4C illustrates abottom perspective view, and FIGS. 4D and 4E illustrate two sideelevational views of the implant 10. In particular, FIG. 4D is anelevational side view of the implant 10 in the XZ-plane viewed from thevantage point of line XX in FIG. 4A and FIG. 4E is an elevational sideview in the YZ-plane viewed from the vantage point of line YY in FIG.4A. As shown by lines XX and YY in FIG. 4A, the two side viewsillustrated in FIGS. 4D and 4E are orthogonal with respect to oneanother. Together, FIGS. 4A-4E illustrate that the implant 10 hasexactly two reflective axes of symmetry about axes X and Y (or,equivalently, has exactly two planes of symmetry about reference planesYZ and XZ). However, it should be appreciated that reflective symmetryabout any two (such as exactly two) suitable axes (or any two (such asexactly two) suitable reference planes) is envisioned, and that anysuitable coordinate system can be used (e.g., spherical coordinates).

FIG. 4F illustrates a two dimensional projection of the perimeter of theimplant 10 onto a frontal XY-plane from the perspective of FIG. 4A.Specifically, FIG. 4F illustrates that the outer profile 11 (alsoreferred to as the perimeter or projection) of the implant 10 definesthe shape of an oval or ellipse. However, other perimeter shapes arealso appreciated, such as, for example, a circle. In certainembodiments, the profile 11 outlines the peripheral edge of the implant10 where the concave lower surface intersects the convex upper surface.As shown in FIG. 4F, the outer profile 11 includes a major axis 12 (alsoreferred to as the longer axis), a minor axis 13 (also referred to asthe shorter axis), and a center 14. The major and minor axes 12, 13 arethe longest and shortest diameters of the outer profile 11,respectively. The major and minor axes 12, 13 are mutually orthogonaland pass through the center 14. In certain embodiments, the minor axis13 is coincident with the X axis and the major axis 12 is coincidentwith the Y axis, although any suitable axis arrangement is envisioned.In certain embodiments, the major and minor axes 12, 13 have lengths of17 cm and 14 cm, respectively. In certain embodiments, the major axis isabout 17 cm, such as between about 12 cm to about 22 cm, about 14 cm toabout 20 cm, or about 15.5 cm to 18.5 cm, among any other suitablerange. In certain embodiments, the minor axis is about 14 cm, such asbetween about 9 cm to about 19 cm, about 11 cm to about 17 cm, or about12.5 cm to about 15.5 cm, among any other suitable range. Other majorand minor axis lengths can include, for example, any suitablecombination of major and minor axes having lengths in the range of 5 cmto 30 cm such that a mathematically defined ovular or ellipticalperimeter and/or peripheral edge results. In certain embodiments, themajor axis length is about 20% greater than the minor axis length, suchas between about 10% and 30% greater, between about 12.5% and 27.5%greater, between about 15% and 25% greater, or between about 17.5% and22.5% greater, among any other suitable range. Further, in certainembodiments, the major and minor axes 12, 13 each comprise an axis ofsymmetry.

Returning to FIGS. 4D and 4E, these figures also show that the implant10 has a width 15, a length 16, and an outer height 17, as measuredalong axes X, Y, and Z. In certain embodiments, the width and length 15,16 correspond to the minor and major axes 13, 12 shown in FIG. 4F. Incertain embodiments, the width 15 is about 14 cm and the length 16 isabout 17 cm, although any suitable dimension of the width and length isappreciated. For example, in certain embodiments, the width and length15, 16 can have any dimension ranging from 5 cm to 30 cm which togethercooperate to mathematically define an oval or ellipse. The outer height17 is measured along the Z-axis between the lowmost point and topmostpoint of the implant 10. For example, for embodiments in which the lowersurface of the implant is concave and the upper surface is convex, theouter height 17 represents the change in height along the Z-axis fromthe lowmost point to the topmost point of the implant as measured fromits peripheral edge where the lower and upper surfaces converge (alsoreferred to as its outer edge), to its topmost center where the uppersurface is at its peak. In embodiments in which the lower surface of theimplant is flat, the outer height 17 represents the change in heightfrom any point on the lower surface of the implant to the topmost pointof the implant where the upper surface is at its peak. In certainembodiments, the outer height 17 is about 3.5 centimeters, although anysuitable outer height 17 is appreciated, such as, for example, betweenabout 1 cm to about 15 cm, about 1 cm to about 10 cm, about 2 cm toabout 8 cm, or about 2.5 to about 6.5 cm, among others. Moreover, incertain embodiments, the vertical distance (e.g., a dimension parallelto the Z axis along which the outer height 17 is measured) between theupper and lower surface in cross section does not taper to zero untilthe peripheral edge of the implant. For example, in some embodiments,the peripheral edge of the implant is formed by the intersection of theupper and lower surface such that the peripheral edge forms a point orsubstantially forms a point.

FIGS. 4G and 4J illustrate two cross-sectional side views of the implant10, both of which cut through the center of the implant and split it inhalf. For example, the cross section shown in FIG. 4G illustrates theimplant 10 in the XZ-plane at line 4G-4G in FIG. 4A, and the crosssection shown in FIG. 4J illustrates the implant 10 in the YZ-plane atline 4J-4J in FIG. 4A. Similarly, FIG. 4M illustrates the implant 10 inthe XZ-plane at line 4M-4M in FIG. 4A, FIG. 4N illustrates the implant10 in the XZ-plane at line 4N-4N in FIG. 4A, FIG. 4O illustrates theimplant 10 in the XZ-plane at line 4O-4O in FIG. 4A, and FIG. 4Pillustrates the implant 10 in the XZ-plane at line 4P-4P in FIG. 4A. Asshown in these figures, the arc lengths can decrease as thecross-sections are taken closer to the peripheral edge of the implant.For example, in certain embodiments, the shapes of the arcs approach oneanother until they merge into a single horizontal line at the peripheraledge of the implant. In certain embodiments, the distance between theupper and lower surfaces can decrease to zero toward the peripheral edgeof the implant. In certain embodiments, the angle between the upper andlower surfaces can decrease to zero toward the peripheral edge of theimplant. As shown in FIGS. 4A-4P, the slope of the surface of theimplant varies.

For example, as shown in FIGS. 4G and 4J, as well as in FIGS. 4A-4P, theimplant 10 has a convex upper surface 10 a and a concave lower surface10 b, although it is appreciated that the upper and lower surfaces canbe adapted to form any suitably shaped surface, such as, for example,flat, more curved, less curved, more convex, less convex, and/orangular, among others. The surfaces can be parametric and/ornon-parametric surfaces. Although FIGS. 4G and 4J illustrate crosssections of the implant 10, it is appreciated that 10 a, 10 b arerepresentative of surfaces, as labeled in FIGS. 4A-4P. In particular,FIGS. 4G and 4J illustrate the implant 10 with a convex upper surface 10a and a concave lower surface 10 b and illustrate the concavity 10 xwith a convex upper surface 10 b and a flat bottom surface 10 c relativeto the peripheral edge of the implant. It should be appreciated that theimplant and concavity 10, 10 x can take on any suitable size and anysuitable shape relative to one another, as well as separately. Forexample, in certain embodiments, the concavity 10 x can be definedrelative to any reference surface below the lower surface 10 b of theimplant 10, such as, for example, a body cavity surface.

FIGS. 4H and 4I separately depict the cross-sectional side views of theimplant and concavity 10, 10 x illustrated together in FIG. 4G, andFIGS. 4K and 4L separately depict the cross-sectional side views of theimplant and concavity 10, 10 x illustrated together in FIG. 4J. Inparticular, FIG. 4H shows a profile 20 of the implant 10 in theXZ-plane, FIG. 4I shows a profile 19 of the concavity 10 x in theXZ-plane, FIG. 4K shows a profile 22 of the implant 10 in the YZ-plane,and FIG. 4L shows a profile 21 of the concavity 10 x in the YZ-plane.The concavity profiles 19, 21 illustrate a concavity height 18 (alsoreferred to as an inner height of the implant) and the implant profiles20, 22 illustrate the outer and inner heights 17, 18. The outer height17 is determined as described above and the inner height 18 is similarlymeasured along the Z axis from a lowmost point along the perimeter ofthe concavity 10 x to a topmost point of the concavity 10 x. In certainembodiments, the inner height 18 is about 1 cm, such as between about0.5 cm to about 1.5 cm, about 0.5 cm to about 2 cm, or about 1 cm toabout 4 cm. Other inner heights are also appreciated, ranging fromapproximately 0.5 cm to approximately 0.5 cm less than the outer height17, which can range from 1 cm to 15 cm, among any other suitable height.

The arcs 23 x, 25 x in FIGS. 4I and 4L correspond to the upper bounds ofthe concavity 10 x in the cross-sectional profiles 19, 21. The innerarcs 23, 25 and the outer arcs 26, 27 in FIGS. 4H and 4K correspond tothe concave lower and convex upper surfaces of the implant 10 in thecross-sectional profiles 20, 22. In certain embodiments, the arcs 23 x,23 are coincident or nearly coincident with each other and the arcs 25x, 25 are coincident or nearly coincident with each other. In certainembodiments, the inner arcs 23, 25 and the outer arcs 26, 27 in FIGS. 4Hand 4K each correspond to a radius of curvature, such as, for example,approximately 25 cm for arc 23, approximately 18 cm for arc 25,approximately 9 cm for arc 26, and approximately 12 cm for arc 27. Othersuitable radii of curvature are also appreciated, such as, for example,any suitable combination of radii ranging from about 5 cm to about 50 cmsuch that the inner arcs 23, 25 form part of the geometrical scaffoldingof the concave surface of the implant 10 and such that the outer arcs26, 27 form part of the geometrical scaffolding of the convex surface ofthe implant 10.

For example, in certain embodiments, the radius of curvature for theouter arc 26 is between about 7.5 cm to about 10.5 cm, about 6 cm toabout 13 cm, or about 4.5 cm to about 14.5 cm., among any other suitablerange. In certain embodiments, the radius of curvature for the inner arc23 is between about 22.5 cm to about 27.5 cm, about 20 cm to about 30cm, or about 17.5 cm to about 32.5 cm, among any other suitable range.In certain embodiments, the radius of curvature for the outer arc 27 isbetween about 10.5 cm to about 13.5 cm, about 9 cm to about 15 cm, orabout 7.5 cm to about 16.5 cm, among any other suitable range. Incertain embodiments, the radius of curvature for the inner arc 25 isbetween about 15.5 cm to about 20.5 cm, about 13 cm to about 23 cm, orabout 10.5 cm to about 25.5 cm, among any other suitable range.

In some embodiments, the outer arc 26 has an arc length that is about16.23 cm, such as between about 16.03 cm to about 16.43 cm, about 15.5cm to about 17.0 cm, about 14 cm to about 18.5 cm, or about 11 cm toabout 21.5 cm, among any other suitable range. In some embodiments, theinner arc 23 has an arc length that is about 14.20 cm, such as betweenabout 14.00 cm to about 14.40 cm, about 12.5 cm to about 15.9 cm, about10 cm to about 18 cm, or about 8.5 cm to about 23 cm, among any othersuitable range. In some embodiments, the arc length of the outer arc 26is about 15% greater than the arc length of the inner arc 23 in the XZplane, such as between about 12% and 18% greater, between about 10% and20% greater or between about 5% and about 30% greater. In someembodiments, the angle between the outer arc 26 and the inner arc 23 atthe point at which they intersect at the peripheral edge of the implantis about 34 degrees, such as between about 33 degrees to about 35degrees, about 30 degrees to about 38 degrees, about 20 degrees to about38 degrees, about 15 degrees to about 40 degrees, or between about 10degrees and 45 degrees, among any other suitable range.

In some embodiments, the outer arc 27 has an arc length that is about18.85 cm, such as between about 18.65 cm to about 19.05 cm, about 17 cmto about 20.5 cm, about 15.5 cm to about 22 cm, or about 13 cm to about24.5 cm, among any other suitable range. In some embodiments, the innerarc 25 has an arc length that is about 17.12 cm, such as between about16.92 cm to about 17.32 cm, about 15.5 cm to about 19 cm, about 14 cm toabout 20.5 cm, or about 12.5 cm to about 23 cm, among any other suitablerange. In some embodiments, the arc length of the outer arc 27 is about15% greater than the arc length of the inner arc 25 in the YZ plane,such as between about 12% and 18% greater, between about 10% and 20%greater or between about 5% and about 30% greater. In some embodiments,the angle between the outer arc 27 and the inner arc 25 at the point atwhich they intersect at the peripheral edge of the implant is about 29degrees, such as between about 28 degrees to about 30 degrees, about 25degrees to about 33 degrees, about 15 degrees to about 36 degrees, about10 degrees to about 38 degrees, or between about 5 degrees and 40degrees, among any other suitable range.

In certain embodiments, the ratio between the radius of curvature of theinner arcs 23, 25 can range from about 0.3 to about 1.7, such as, forexample, approximately 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3,1.4, 1.5, 1.6, or 1.7 or ranges incorporating any two of the precedingvalues. In certain embodiments, the ratio between the outer arcs 26, 27can range from about 0.3 to about 3, such as, for example, approximately0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7,1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or 3.0, orranges incorporating any two of the preceding values. In certainembodiments, the ratio between inner arc 23 and outer arc 26 can rangefrom about 1.5 to about 6, such as, for example, approximately 1.5, 1.6,1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0,3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7, 4.0, 5.0, or 6.0, or rangesincorporating any two of the preceding values. In certain embodiments,the ratio between inner arc 25 and outer arc 27 can range from about 1.1to about 3, such as, for example, approximately 1.1, 1.2, 1.3, 1.4, 1.5,1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, or3.0, or ranges incorporating any two of the preceding values. Othersuitable ratios are also appreciated. Such ratios advantageously makethe implant 10 more aesthetically pleasing while also making it morestable in some embodiments. In some embodiments, any or all of theforegoing ratios are not 1.0.

In view of the aforementioned geometric parameters, and as describedabove, the implant 10 is not in some embodiments a truncated ovoid in astrict geometrical sense. Even so, the implant 10 is an illustration ofa truncated approximately ovoid implant. This is because the implant 10has the look and appearance of a truncated ovoid even though itsgeometric properties say otherwise. Thus, the implant 10 is described asa truncated approximately ovoid implant.

With reference to FIGS. 9A and 9B, these two figures illustrate the typeof two dimensional shapes formed at the cross-sections depicted in FIGS.4H and 4K. For example, FIG. 9A shows the relative curvature between theupper and lower surfaces shown in FIG. 4H, and FIG. 9B shows therelative curvature between the upper and lower surfaces shown in FIG.4K. Similarly, FIGS. 10A and 10B illustrate two figures that show thetwo dimensional shapes that are formed at the center cross-sectionsdepicted in FIGS. 5H and 5K. For example, FIG. 10A shows the relativecurvature between the upper and lower surfaces shown in FIG. 5H, andFIG. 10B shows the relative curvature between the upper and lowersurfaces shown in FIG. 5K.

With reference to FIGS. 5A-5P, in certain embodiments, the inner arcs23, 25 and the outer arcs 26, 27 in FIGS. 5H and 5K have curvatures thatvary according to an ellipse. For example, in certain embodiments, theinner arcs 23, 25 and the outer arcs 26, 27 in FIGS. 5H and 5Kcorrespond to a semi-minor or semi-major axis of an ellipse. In certainembodiments, the arcs 23, 25, 26, 27 correspond to semi-minor/major axesranging from about 7 cm to about 40 cm, such as, for example,approximately 24 cm for arc 23, 17 cm for arc 25, 10 cm for arc 26, and13 cm for arc 27. Other suitable semi-minor and semi-major axes are alsoappreciated, such as, for example, any suitable combination of axesdefining an ellipsoid ranging from about 5 cm to about 50 cm such thatthe inner arcs 23, 25 form part of the geometrical scaffolding of theconcave surface of the implant 10′ and such that the outer arcs 26, 27form part of the geometrical scaffolding of the convex surface of theimplant 10′.

In some embodiments, the inner arc of the upper surface and the innerarc of the lower surface are different, but within about 5% to about 10%of each other, within about 5% to about 20% of each other, within about5% to about 40% of each other, or any other suitable percentage. In someembodiments, the outer arc of the lower surface and the outer arc of theupper surface are difference, but within about 5% to about 10% of eachother, within about 5% to about 20% of each other, within about 5% toabout 40% of each other of each other.

Again referencing FIGS. 4A-4P and 5A-5P together as discussed above, theimplant 10 can be used in any anatomical location. The implant 10 can beformed to correspond to a natural and/or desired size and shape of anyanatomical location while the body is static (e.g., upright, bent over,supine, prone, or any position in which the body is “frozen” in time) orin motion (e.g., walking, running, jumping, or any other movement). Forexample, in certain embodiments, the implant 10 is formed to correspondto a desired and/or natural shape of the left or right cheek of thebuttocks, or a portion thereof. As shown and described above, theimplant 10 can be a truncated approximately ovoid implant bounded byconvex upper and concave lower surfaces 10 a, 10 b, with other truncatedshapes also being appreciated, such as, for example, ellipsoids,approximately ellipsoidal, substantially ellipsoidal, ovoids,substantially ovoidal spheres, approximately spherical, substantiallyspherical spheroids, approximately spheroidal, teardropoids,approximately teardropoidal, substantially teardropoidal, paraboloids,approximately paraboloidal, polygonoids, approximately polygonoidal, orsubstantially polygonoidal, among any other suitable shape having curvedand/or angular surfaces, including shapes with parametric and/ornon-parametric surfaces. In certain embodiments, the convex uppersurface of the implant has a continuous curvature. For example, incertain embodiments, the convex upper surface can form a single unitarypiece of the implant. The continuous curvature of the convex uppersurface can define an apex with a smooth surface which forms the topmostpoint of the implant. The apex may or may not be centered with respectto convex upper surface (e.g., it can be centered or off-centered). Incertain embodiments, the concave lower surface has a continuouscurvature. For example, in certain embodiments, the concave lowersurface can form a single unitary piece of the implant. The continuouscurvature of the concave lower surface can define a depression into thebody of the implant that substantially mirrors the shape of the convexupper surface. In other embodiments, the convex upper surface andconcave lower surface can be angular such that it approximates a smoothsurface, and in certain embodiments, the upper and lower surfaces canhave angled portions in addition to curved portions. In certainembodiments the lower surface is concave to cup the underlying tissuefor a better fit. Advantageously, the concavity of the lower surface canhelp reduce or eliminate the risk of mal-rotation and/or mal-translationevents. For example, in certain embodiments, the concavity can be shapedto form a suction force against the underlying tissue upon implantationto prevent or reduce the occurrence of mal-rotation and/ormal-translation events. In certain embodiments, the surface of theconcavity can be smooth or coarse. When the surface is coarse, thesurface of the concavity can generate friction between the concave lowersurface and the tissue so that it takes more force to mal-rotate and/ormal-translate the implant. In some embodiments, when the surface of theconcavity is smooth, the concave surface can include one or more tissuehooks configured to extend into the tissue and prevent mal-translationand/or mal-rotation.

While in certain embodiments well-known geometric shapes and/or surfacesare used to form the implants shown and described herein, customizedshapes and/or surfaces are appreciated as well and can be used in lieuof or in tandem therewith. In addition, in certain embodiments, suchcustomized shapes can approximate well-known geometric shapes. Forexample, the implant 10 in FIGS. 4A-4P approximates a truncated ovoid.However, other approximations are also possible, such as, for example,ellipsoids, spheres, spheroids, teardropoids, paraboloids, orpolygonoids, as well as truncations thereof.

The shapes and/or surfaces of the implant can be chosen, designed,and/or formed according to the body region in which the implant will beimplanted, in addition to myriad other factors. For example, FIGS. 4A-4Pshow an implant 10 having a truncated approximately or substantiallyovoid shape for the left or right buttock, and which can be formed inseveral ways. For example, in certain embodiments, the lower concave andupper convex surfaces 10 b, 10 a of the truncated approximately orsubstantially ovoid implant 10 can be formed by creating the inner andouter arc 23, 25 arrangement depicted in FIG. 4H in a computer-aideddesign (CAD) computer program. This arc section can then be pulledsimultaneously in a first lengthwise direction and a second downwarddirection until its perimeter profile matches that of half of theprofile 11 depicted in FIG. 4F and such that its inner and outer arc 25,27 in the plane orthogonally centered with respect to the planecontaining the inner and outer arc 23, 25 have the radii shown in FIG.4K. This graphical extrusion can then be reflected across the planecontaining the inner and outer arc 23, 25 to complete the truncatedapproximately ovoid implant 10. Of course, any suitable combination ofarcs that intersect and terminate at two points is also appreciated, asis any suitable subsequent extrusion and reflection that ultimately formthe implant.

Generally, in certain embodiments, the convex upper and concave lowersurfaces of an implant can be formed from any two like shaped surfaces,such as, for example, ellipsoidal surfaces, approximately ellipsoidalsurfaces, and/or substantially ellipsoidal surfaces, or ovoidalsurfaces, approximately ovoidal surfaces, and/or substantially ovoidalsurfaces, or spherical surfaces, approximately spherical surfaces,and/or substantially spherical surfaces, or spheroidal surfaces,approximately spheroidal surfaces, and/or substantially sphericalsurfaces, or teardropoidal surfaces, approximately teardropoidalsurfaces, and/or substantially teardropoidal surfaces, or cylindricalsurfaces, approximately cylindrical surfaces, and/or substantiallycylindrical surfaces, or polygonal surfaces, approximately polygonalsurfaces, and/or substantially polygonal surfaces, or paraboloidalsurfaces, approximately paraboloidal surfaces, and/or substantiallyparaboloidal surfaces, among others, including shapes with parametricand/or non-parametric surfaces. In other embodiments, the convex upperand concave lower surfaces 10 a, 10 b have different relative shapes ora combination of two or more shaped surfaces, with the upper convexsurface forming a first surface and the lower concave surface forming asecond surface. For example, in certain embodiments, the upper surfacecan be formed from an ellipsoidal surface, an approximately ellipsoidal,or a substantially ellipsoidal surface and the lower surface can beformed from any suitable shaped surface different from ellipsoidal,approximately ellipsoidal, or substantially ellipsoidal such as, forexample, ovoidal, approximately ovoidal, substantially ovoidal,spherical, approximately spherical, substantially spherical, spheroidal,approximately spheroidal, substantially spheroidal, teardropoidal,approximately teardropoidal, substantially teardropoidal, cylindrical,approximately cylindrical, substantially cylindrical, polygonal,approximately polygonal, or substantially polygonal, among others,including shapes with parametric and/or non-parametric surfaces. Instill other embodiments, the upper and lower surfaces 10 a, 10 b can beany suitably shaped surface as discussed above.

However, in certain embodiments it is advantageous not to have the upperand/or lower surface of the implant be cylindrical shaped, such ascylindrical or approximately cylindrical (e.g., having a substantiallyconstant height along at least a portion of the lower surface) because acylindrical or approximately cylindrical lower surface will encouragethe implant to translate along the cylindrical axis and also make itharder to rotate the implant back into an equilibrium position followinga post-operative movement (e.g., because the edges of the lower surfaceare more likely to catch tissue and make rotation harder).

Further, in certain embodiments, it is advantageous to use shapes thatare truncated ovoids, truncated approximate ovoids, substantiallytruncated ovoids, truncated ellipsoids, truncated approximateellipsoids, or substantially truncated ellipsoids instead of truncatedspheres, truncated approximate spheres, or substantially truncatedspheres because, for similar sized three dimensional bodies, the formerlist conforms better to the buttock region and muscle insertion pointsthan truncated spheres or truncated approximate spheres. For example,truncated spheres, truncated approximate spheres, or substantiallytruncated spheres typically have peaks that are too short (i.e., thepeak of the convex upper surface of the implant is not high enough), andthey typically aren't large enough to reach the back of the thigh. As aresult, truncated spheres, truncated approximate spheres, orsubstantially truncated spheres typically have less desirable aestheticproperties upon implantation when compared to truncated ovoids,truncated approximate ovoids, substantially truncated ovoids, truncatedellipsoids, truncated approximate ellipsoids, or substantially truncatedellipsoids.

For example, with reference to FIGS. 5A-5P, the upper surface 10 a canbe formed from the surface of a first ellipsoid, the upper surface 10 abeing a truncated portion thereof, and the lower surface 10 b can beformed from the surface of a second ellipsoid, the lower surface 10 bbeing a truncated portion thereof, such that the upper and lowersurfaces 10 a, 10 b are formed from a truncated surface of the first andsecond ellipsoid, respectively. Thus, in certain embodiments, theimplant 10 is formed from a single ellipsoid while its upper and lowersurfaces 10 a, 10 b are defined by the truncated surfaces of twoellipsoids.

In certain embodiments, the implant 10′ can be formed from one or morethree dimensional bodies and/or surfaces. For example, FIGS. 6A and 6Billustrate two ellipsoids that are capable of forming the implant 10′.In particular, FIG. 6A illustrates a first ellipsoid 30 a which formsthe implant 10′ and its upper surface 10 a, and FIG. 6B illustrates asecond ellipsoid 30 b which forms the lower surface 10 b of the implant10. In Cartesian coordinates, the first and second ellipsoid 30 a, 30 bare defined by:x ² /a ² +y ² /b ² +z ² /c ²=1,where a, b, and c correspond to the semi-major and semi-minor axes ofthe three ellipses that are formed at the three axial cross-sectionscoincident with the XY-plane, XZ-plane, and YZ-plane, and where thepoints (a,0,0), (0,b,0), and (0,0,c) correspond to surface coordinates.For example, FIGS. 6A and 6B, show semi-major axes c₁, c₂ and semi-minoraxes b₁, b₂ in the XY-plane, semi-major axes b₁, b₂ and semi-minor axesa₁, a₂ in the XZ-plane, and semi-major axes c₁, c₂ and semi-minor axesa₁, a₂ in the YZ-plane. FIG. 6C illustrates the implant 10′ formed bythe combination of the first and second ellipsoids 30 a, 30 b. Incertain embodiments, a₁, a₂, b₁, b₂, c₁, and c₂ are chosen such that theimplant has a convex upper surface and a concave lower surface asdescribed above with reference to FIGS. 4A-4P and 5A-5P.

Further, in certain embodiments, the semi-major axis c and thesemi-minor axis b of the first and/or second ellipsoid 30 a, 30 b in theXY-plane correspond to the semi-major axis and semi-minor axis of thetwo dimensional projection of the perimeter of the implant in theXY-plane, depending on the size and extent of the truncation.

As discussed above, in certain embodiments, the size and shape of theimplant 10 is formed so that it has one or more positions of stabilityupon implantation, such as for example two equilibrium positions. Forexample, FIGS. 7A-7C illustrate the implant 10 of FIGS. 4A-4P in threesequential positions (e.g., a first equilibrium position, a firstnon-equilibrium position, and a second equilibrium position), althoughany suitable implant is appreciated. In FIG. 7A, two implanted implants10 are shown aligned with axes E in an equilibrium position. In FIG. 7B,the two implants have been rotated out of their equilibrium positionsand are now aligned with axes R. FIG. 7C illustrates the implants 10 inFIG. 7B rotated back into an equilibrium position and again aligned withaxes E.

FIGS. 11-18 illustrate additional views of the implant 10 depicted inFIGS. 4A-4P. For example, FIG. 11 illustrates a top perspective view ofthe implant of FIGS. 4A-4P, FIG. 12 illustrates a bottom perspectiveview of the implant of FIGS. 4A-4P, FIG. 13 illustrates a front view ofthe implant of FIGS. 4A-4P, FIG. 14 illustrates a rear view of theimplant of FIGS. 4A-4P, FIG. 15 illustrates a left side view of theimplant of FIGS. 4A-4P, FIG. 16 illustrates a right side view of theimplant of FIGS. 4A-4P, FIG. 17 illustrates a top plan view of theimplant of FIGS. 4A-4P, FIG. 18 illustrates a bottom plan view of theimplant of FIGS. 4A-4P.

Depending on patient anatomy and patient preferences, the same sizedoval implant might be used for both the left and right implant, but thisis not required. For example, left and right implants of different sizesand different shapes can easily be combined and result in a balancedpost-surgical aesthetic appearance. In yet other embodiments, anunrestrained symmetrical infinity shaped ovoid or approximately ovoidimplant system is used to help solve the problem of post-operationimplant movement. In these embodiments, the implant system is a type ofhybrid between the restrained asymmetrical implant systems and theunrestrained implants described above. For example, these embodimentshave symmetry about two axes, and although unrestrained, have left andright buttock implants that are nevertheless connected. Similar to theimplants described above, infinity shaped ovoid or approximately ovoidimplant systems can also act to mitigate and potentially eliminate therisk of mal-rotation and mal-translation events due to their large sizeand expansive anatomical presence. The size and shape of infinity shapedovoid or approximately ovoid implant systems are designed to resistpost-operative implant movement.

FIGS. 8A-8O illustrate various views of an exemplary infinity shapedimplant 40 with a concave lower surface. For example, in certainembodiments, the infinity shaped implant 40 is a truncated ovoid orapproximately ovoid implant with a concave lower surface Specifically,FIG. 8A illustrates a top view, FIG. 8B illustrates a perspective view,and FIGS. 8C and 8D illustrate side views of a symmetrical infinityshaped ovoid or approximately ovoid implant system 40. Together, FIGS.8A-8D show that the symmetrical infinity shaped implant system 40 hastwo axes of symmetry about axes X and Y. FIG. 8E illustrates the outerprofile 41 of the infinity shaped implant system 40. The outer profile41 is formed by joining two symmetric ovals together. In certainembodiments, outer profile 41 comprises two separate oval profiles 44and 47 joined together at a horizontal center line 42 by a connectingarc 50 on each side. The oval profiles 44 and 45 have the symmetrydescribed above with reference to FIG. 4F. In certain embodiments, thehorizontal center line 42 is parallel to major axes 45 and 48 of ovalprofiles 44 and 47, respectively, and defines an inner waist of outerprofile 41. In certain embodiments, the major axes 45 and 48 are aconstant separating distance 52 apart and a distance 51 from thehorizontal center line. Moreover, the minor axes 46 and 49 of ovalprofiles 44 and 47, respectively, are coincident with one another nearthe horizontal center line 42. In certain embodiments, the minor axes 46and 49 together define a vertical center line 43 that runs the length ofouter implant profile 41 as shown in FIG. 8E. As shown, the infinityovoid implant system is symmetric about the horizontal center line 42and the vertical center line 43. In certain embodiments, the major axes45 and 48, minor axes 46 and 49, distance 51, and separating distance 52have lengths of approximately 12 cm, 10 cm, 3 cm, and 7 cm,respectively, and the connecting arc 50 has a radius of approximately 4centimeters. Other suitable lengths and radii are appreciated. Forexample, the major axes 45 and 48, minor axes 46 and 49, distance 51,and separating distance 52 may range from approximately 7-16 cm, 8-12cm, 2-6 cm, and 5-9 cm, respectively, and the connecting arc 51 mayrange from 2-6 cm. In addition, the ratio of the inner waist, orhorizontal center line 42, to the major axes 45 and 48 is about 0.88 inFIG. 8E. However, other ratios are appreciated. For example, the ratioof the inner waist to the major axes may range, for example, frombetween about 0.75 to about 0.97, between about 0.80 and about 0.95,between about 0.85 and about 0.90, or about 0.75, 0.76, 0.77, 0.78,0.79, 0.80, 0.81, 0.82, 0.83, 0.84, 0.85, 0.86, 0.87, 0.88, 0.89, 0.90,0.91, 0.92, 0.93, 0.94, 0.95, 0.96, or 0.97.

FIGS. 8C and 8D further illustrate side views of the infinity shapedimplant system 40 shown in FIGS. 8A and 8B. In particular, FIG. 8C is aside view in the XZ-plane and FIG. 8D is a side view in the YZ-plane. Asshown, the implant is symmetrical across the Z axis in both figures.

FIGS. 8F and 8I illustrate center side view cross-sections in the XZ-and YZ-planes at line 8F-8F in FIG. 8A and at line 8I-8I in FIG. 8C,respectively, of a concave infinity shaped implant. In particular, FIGS.8F and 8I illustrate cross sections of the implant 40 and a concavity 40x. Similarly, FIG. 8L illustrates the implant in the XZ-plane at line8L-8L in FIG. 8A, FIG. 8M illustrates the implant in the XZ-plane atline 8M-8M in FIG. 8A, FIG. 8N illustrates the implant in the XZ-planeat line 8N-8N in FIG. 8A, and FIG. 8O illustrates the implant in theXZ-plane at line 8O-8O in FIG. 8A. As shown in these figures, the arclengths can decrease as the cross-sections are taken closer to theperipheral edge of the implant. For example, in certain embodiments, theshapes of the arcs approach one another until they merge into a singlehorizontal line at the peripheral edge of the implant. In certainembodiments, the distance between the upper and lower surfaces candecrease to zero toward the peripheral edge of the implant. In certainembodiments, the angle between the upper and lower surfaces can decreaseto zero toward the peripheral edge of the implant. As shown in FIGS.8A-8O, the slope of the surface of the implant varies.

In particular, FIG. 8G illustrates a narrow center concavity profile 60in the XZ-plane and FIG. 8H illustrates the corresponding narrow centerimplant profile 70 in the XZ-plane. The exemplary cross sections inFIGS. 8G and 8H are at the narrowest point of the infinity ovoid implantsystem along the horizontal center line 42 shown in FIG. 8E. In certainembodiments, the concavity profile 60 is defined by horizontalcenterline length 63, narrow lower concavity radius 64, and narrow upperconcavity radius 65 as shown in FIG. 8G. In certain embodiments, thevertical distance between the highest point of the narrow lowerconcavity radius 64 and the horizontal centerline length 63 is thenarrow lower concavity height 61 and the vertical distance between thehighest point of the narrow upper concavity radius 65 and the horizontalcenterline length 63 is the narrow upper concavity height 62. In certainembodiments, the horizontal centerline length 63, narrow lower concavityradius 64, narrow upper concavity radius 65, narrow lower concavityheight 61, and narrow upper concavity height 62 have lengths or radii ofapproximately 11 cm, 16 cm, 15 cm, 0.9 cm, and 1 cm, respectively. Othersuitable lengths and radii are appreciated. For example, the horizontalcenterline length 63, narrow lower concavity radius 64, narrow upperconcavity radius 65, narrow lower concavity height 61, and narrow upperconcavity height 62 can have lengths and radii that respectively rangefrom approximately 8-14 cm, 12-20 cm, 0.5-1.5 cm, and 0.5-1.5 cm.

In certain embodiments, the narrow center implant profile 70 is definedby horizontal centerline length 63 and narrow implant radius 71 as shownin FIG. 8H. In certain embodiments, the vertical distance between thehighest point of the narrow implant radius 71 and the horizontalcenterline length 63 is the narrow implant height 72. In certainembodiments, the horizontal centerline length 63, narrow implant radius71, and narrow implant height 72 have lengths and a radius ofapproximately 11 cm, 6 cm, and 3.5 cm, respectively. Other suitablelengths and radii are appreciated. For example, the horizontalcenterline length 63, narrow implant radius 71, and narrow implantheight 72 can have lengths and radii that respectively range fromapproximately 8-14 cm, 3.5-9 cm, and 2.5-6 cm.

Similarly, FIG. 8J illustrates a wide center concavity profile 80 in theYZ-plane and FIG. 8K illustrates the corresponding wide center implantprofile 90 in the YZ-plane. The exemplary cross sections in FIGS. 8J and8K are at the widest point of the infinity ovoid implant system alongthe union of minor axes 46 and 49 shown in FIG. 8E. In certainembodiments, the wide center concavity profile 80 is defined by distance83, which is the line created via some combination of both minor axes 46and 49 shown in FIG. 5F, and the wide concavity radius 81. In certainembodiments, the vertical distance between distance 83 and the highestpoint of the wide concavity radius 81 is the wide concavity height 82.In certain embodiments, distance 83, wide concavity radius 81, and wideconcavity height 82 have lengths and a radius of approximately 17 cm, 52cm, and 1 cm, respectively. Other suitable lengths and radii areappreciated. For example, distance 83, wide concavity radius 81, andwide concavity height 82 may have lengths and radii that respectivelyrange from approximately 12-22 cm, 45-57 cm, and 0.5-1.5 cm.

As shown in FIG. 8K, in certain embodiments, the wide center implantprofile 90 is defined by is defined by distance 83, which is the linecreated via some combination of both minor axes 46 and 49 shown in FIG.8E, and wide lower implant radius 94, and wide upper implant radius 95.In certain embodiments, the vertical distance between the highest pointof wide lower implant radius 94 and distance 83 is the wide lowerimplant height 91 and the vertical distance between the highest point ofwide upper implant radius 95 and distance 83 is the wide upper implantheight 92. In certain embodiments, distance 83, wide lower implantradius 94, wide upper implant radius 95, wide lower implant height 91,and wide upper implant height 92 have lengths or radii of approximately17 cm, 5 cm, 17.5 cm, 2 cm, and 3.5 cm, respectively. Other suitablelengths and radii are appreciated. For example, distance 83, wide lowerimplant radius 94, wide upper implant radius 95, wide lower implantheight 91, and wide upper implant height 92 may have lengths and radiithat respectively range from approximately 12-22 cm, 3-8 cm, 14-21 cm,1.5-3.5 cm, and 2-5 cm.

The implants and implant systems shown and described herein can bemanufactured from, for example, silicone or silicone reinforced with amaterial such as Dacron, polystyrene, polypropylene, propylene, prolene,PTFE, ePTFE, composite materials and other natural, biological andsynthetic materials. The silicone rubber material durometer, orsoftness, at the implant surfaces can range from “A-scale” 50-20, suchas about 50, 45, 40, 35, 30, 25, 20, or ranges including one or more ofthe foregoing values, and can range from “00-scale” 50-“000-scale” 10 atthe implant center, such that the implant shape is stable. In certainembodiments, the implants and implant systems described herein areformed by injection molding, or any other suitable process. In someembodiments, the implant, e.g., the outer shell of the implant is notmade of a plastic material. In some embodiments, the implant has aflexible body that is not rigid to mimic natural body contours,including the buttocks, and is configured such that the surroundingnative tissue can move vis-à-vis the implant. The implant can have asmooth or textured surface in some embodiments.

Further, the implants and implant systems can include a body thatincludes a shell having one unitary layer, or a plurality of layers,such as 2, 3, 4, or more layers and filled or configured to besubstantially filled with a filler such as a viscous flowable material,and/or a foam. The viscous material can be selected for a combination ofnon-toxicity as well as to provide structural support to the surroundingtissue while maintaining a natural feel. For example, the viscousmaterial can include saline, water, silicone, silicone gel, atriglyceride oil, a block co-polymer, or other materials. In someembodiments, the implant can be configured to be filled with any desiredvolume, such as for example between about 200 cc and about 1000 cc orbetween about 200 cc and about 800 cc.

In certain embodiments, a method includes implanting any of theembodiments shown and/or described herein into a human body, the methodcomprising preparing a surgical site, forming a cavity for the implant,and implanting the embodiment in the surgically created cavity. Any ofthe embodiments shown and/or described herein can be utilized, forexample, for breast or buttock augmentation and/or reconstruction. Insome embodiments, the implant is configured to be a permanentimplantable prosthesis for insertion in the body for at least about 1,2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 25 years, and not as a temporaryimplant, such as after reconstructions for example.

Other Embodiments

The following described embodiments are other embodiments contemplatedby this disclosure:

1. An implantable gluteoplasty system comprising:

-   -   a first gluteal implant and a second gluteal implant;    -   at least one connector configured to connect the first gluteal        implant and the second gluteal implant, the at least one        connector configured to restrain the plurality of implants from        at least one of mal-rotation and mal-translation; and    -   a first fastener configured to secure the at least one connector        to the first gluteal implant and a second fastener configured to        secure the at least one connector to the second gluteal implant.

2. The implantable gluteoplasty system of embodiment 1, wherein thefirst and second gluteal implants each comprise a feature configured toreceive the at least one connector and at least one of the fasteners.

3. The implantable gluteoplasty system of embodiment 2, wherein thefeature comprises a surface depression.

4. The implantable gluteoplasty system of embodiment 3, wherein thesurface depression comprises one or more restraining grooves configuredto receive a portion of the at least one connector and comprises one ormore apertures configured to receive one or more of the fasteners and aportion of the at least one connector, the one or more apertures furtherconfigured such one or more the apertures are proximate to each terminalend of the one or more restraining grooves.

5. The implantable gluteoplasty system of embodiment 4, wherein the oneor more apertures each comprise a surface cavity and an interior cavity,the surface cavity configured to receive a portion of the at least oneconnector and a portion of at least one of the fasteners and theinterior cavity configured to receive a portion of at least one of thefasteners.

6. The implantable gluteoplasty system of embodiment 1, wherein the atleast one connector further comprises a central elongate member having aproximal end and a distal end, wherein the proximal end and the distalend are proximate one or more implant attachment features.

7. The implantable gluteoplasty system of embodiment 6, wherein thecentral elongate member has a fixed length.

8. The implantable gluteoplasty system of embodiment 6, wherein thecentral elongate member has an adjustable length.

9. The implantable gluteoplasty system of embodiment 6, wherein the oneor more implant attachment features comprise one or more rings.

10. The implantable gluteoplasty system of embodiment 9, wherein the oneor more rings are detachable.

11. The implantable gluteoplasty system of embodiment 1, wherein thefirst gluteal implant is configured for implantation in a left buttockand the second gluteal implant is configured for implantation in a rightbuttock.

12. The implantable gluteoplasty system of embodiment 1, wherein thefirst gluteal implant and the second gluteal implant are one of ovoidshaped and ellipsoid shaped.

13. The implantable gluteoplasty system of embodiment 1, wherein thefirst gluteal implant and the second gluteal implant are one ofapproximately ovoid shaped and approximately ellipsoid shaped.

14. The implantable gluteoplasty system of embodiment 1, wherein the atleast one connector is configured to exert a tension force on the firstgluteal implant and the second gluteal implant.

15. An implantable gluteoplasty system comprising:

-   -   a gluteal implant having an infinity shape.

16. The implantable gluteoplasty system of embodiment 15, wherein theinfinity shape comprises two symmetrical implants joined together.

17. The implantable gluteoplasty system of embodiment 16, wherein thetwo symmetrical implants are joined together by a connecting arcdefining an inner waist of the implant.

18. The implantable gluteoplasty system of embodiment 16, wherein thetwo symmetrical implants comprise a first and second gluteal implanthaving symmetrical ovoid shapes.

19. The implantable gluteoplasty system of embodiment 16, wherein thetwo symmetrical implants comprise a first and second gluteal implanthaving symmetrical approximately ovoid shapes.

20. The implantable gluteoplasty system of embodiment 16, wherein thetwo symmetrical implants comprise a first and second gluteal implanthaving symmetrical ellipsoid shapes.

21. The implantable gluteoplasty system of embodiment 16, wherein thetwo symmetrical implants comprise a first and second gluteal implanthaving symmetrical approximately ellipsoid shapes.

22. The implantable gluteoplasty system of embodiment 16, wherein theinfinity shaped gluteal implant is concave.

23. An implantable gluteoplasty system comprising:

-   -   a first gluteal implant and a second gluteal implant, wherein        the first and second gluteal implants are each symmetrical        across two coordinate planes.

24. The implantable gluteoplasty system of embodiment 23, wherein thefirst and second gluteal implants are symmetrical ovoid implants.

25. The implantable gluteoplasty system of embodiment 23, wherein thefirst and second gluteal implants are symmetrical ellipsoid implants.

26. The implantable gluteoplasty system of embodiment 23, wherein thefirst and second gluteal implants are concave.

27. The implantable gluteoplasty system of embodiment 23, wherein thefirst and second gluteal implants are not “tear-drop” shaped.

Any apparatus and method described in this application can include anycombination of the preceding features described in this and otherparagraphs, among other features and combinations described herein,including features and combinations described in subsequent paragraphs,and including any features and combinations described in any applicationincorporated by reference herein.

Various other modifications, adaptations, and alternative designs are ofcourse possible in light of the above teachings. For example, whilegenerally described in the context of gluteal implants, embodimentscould also be applied to other anatomical locations such as breastimplants for example. Therefore, it should be understood at this timethat within the scope of any appended claims the invention may bepracticed otherwise than as specifically described herein. It iscontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments disclosed above may bemade and still fall within one or more of the inventions. Further, thedisclosure herein of any particular feature, aspect, method, property,characteristic, quality, attribute, element, or the like in connectionwith an embodiment can be used in all other embodiments set forthherein. Accordingly, it should be understood that various features andaspects of the disclosed embodiments can be combined with or substitutedfor one another in order to form varying modes of the disclosedinventions. Thus, it is intended that the scope of the presentinventions herein disclosed should not be limited by the particulardisclosed embodiments described above. Moreover, while the invention issusceptible to various modifications, and alternative forms, specificexamples thereof have been shown in the drawings and are hereindescribed in detail. It should be understood, however, that theinvention is not to be limited to the particular forms or methodsdisclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the various embodiments described and the appended claims.Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. The rangesdisclosed herein also encompass any and all overlap, sub-ranges, andcombinations thereof. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “approximately”, “about”, and“substantially” as used herein include the recited numbers (e.g., about10%=10%), and also represent an amount close to the stated amount thatstill performs a desired function or achieves a desired result. Forexample, the terms “approximately”, “about”, and “substantially” mayrefer to an amount that is within less than 10% of, within less than 5%of, within less than 1% of, within less than 0.1% of, and within lessthan 0.01% of the stated amount.

What is claimed is:
 1. A gluteal implant comprising: a body comprising:a convex upper surface; a concave lower surface; and a peripheral edge,the edge defined by the intersection between the convex upper surfaceand the concave lower surface, wherein the body is symmetrical acrosstwo orthogonal reference planes and comprises one of a truncated ovoidshape, a truncated approximate ovoid shape, a truncated ellipsoid shape,and a truncated approximate ellipsoid shape, wherein the convex uppersurface comprises one of a portion of a first surface selected from thegroup consisting of: an ovoid surface, an approximate ovoid surface, anellipsoid surface, and an approximate ellipsoid surface, said firstsurface having a first semi-major axis and a first radius of curvatureand a first semi-minor axis and a second radius of curvature, whereinthe concave lower surface comprises one of a portion of a second surfaceselected from the group consisting of: an ovoid surface, an approximateovoid surface, an ellipsoid surface, and an approximate ellipsoidsurface, said second surface having a second semi-major axis and a thirdradius of curvature and a second semi-minor axis and a fourth radius ofcurvature, wherein the first radius of curvature differs from the thirdradius of curvature, wherein the difference is between about 2.22 cm andabout 2.62 cm, wherein the second radius of curvature differs from thefourth radius of curvature, wherein the difference is between about 2.72cm and about 3.12 cm, wherein the convex upper surface and the concavelower surface intersect at an angle ranging from about 25 degrees toabout 39 degrees, wherein the convex upper surface forms a peak of theimplant, wherein the concave lower surface forms a peak of a concavity,wherein the edge forms a bottommost point of the implant, wherein theedge outlines an oval or ellipse when viewed from above, wherein a ratiobetween the first radius of curvature and the second radius of curvatureis in a range from about 0.3 to about 3.0, wherein a ratio between thethird radius of curvature and the fourth radius of curvature is in arange from about 0.3 to about 1.7, wherein a ratio between the firstradius of curvature and the third radius of curvature is in a range fromabout 1.1 to about 3.0, wherein a ratio between the second radius ofcurvature and the fourth radius of curvature is in a range from about1.5 to about 6.0, wherein the shape of the body is configured to haverotational symmetry that conceals the effects of post-operativemovement, wherein the shape of the body is configured to facilitatemovement toward an equilibrium position following post-operativemovement away from an equilibrium position, wherein post-operativemovement includes mal-translation or mal-rotation, wherein the bodycomprises a unitary piece of material, and wherein the concave uppersurface and concave lower surface are smooth surfaces.
 2. The glutealimplant of claim 1, wherein the shape of the body is configured toresist post-operative movement away from an equilibrium position,wherein post-operative movement includes mal-translation ormal-rotation.
 3. The gluteal implant of claim 1, wherein the shape ofthe body is configured to facilitate movement toward an equilibriumposition following post-operative movement away from an equilibriumposition, wherein post-operative movement includes mal-translation ormal-rotation.
 4. The gluteal implant of claim 1, wherein the bodycomprises a truncated ellipsoid shape, wherein the convex upper surfacecomprises a portion of an ellipsoid surface, and wherein the concavelower surface comprises a portion of an ellipsoid surface.
 5. Thegluteal implant of claim 1, wherein the body comprises a truncatedapproximate ovoid shape, wherein the convex upper surface comprises aportion of an approximate ovoid surface, and wherein the concave lowersurface comprises a portion of an approximate ovoid surface.
 6. Thegluteal implant of claim 1, wherein the convex upper surface has aradius of curvature of about 9 cm when viewed in cross section in afirst plane and a radius of curvature of about 12 cm when viewed incross section in a second plane orthogonal to the first plane, andwherein the concave lower surface has a radius of curvature of about 25cm when viewed in cross section in the first plane and a radius ofcurvature of about 18 cm when viewed in cross section in the secondplane.
 7. The gluteal implant of claim 1, wherein the convex uppersurface has a radius of curvature in the range of from about 5 cm toabout 15 cm when viewed in cross section in a first plane and a radiusof curvature in the range of from about 7 cm to about 18 cm when viewedin cross section in a second plane orthogonal to the first plane, andwherein the concave lower surface has a radius of curvature in the rangeof from about 18 cm to about 32 cm when viewed in cross section in thefirst plane and a radius of curvature in the range of from about 11 cmto about 25 cm when viewed in cross section in the second plane.
 8. Thegluteal implant of claim 1, wherein the angle of intersection variesalong the edge of the implant.
 9. The gluteal implant of claim 1,wherein the body is not “tear-drop” shaped.
 10. The gluteal implant ofclaim 1, wherein the body is made of silicone.
 11. A gluteal implantsystem comprising: a first gluteal implant and a second gluteal implant,the first and second gluteal implants having convex curved superiorfirst and concave second inferior surfaces, the curvature of the firstsurface being different from the curvature of the second surface,wherein the first and second gluteal implants have reflective symmetryabout exactly two orthogonal planes, wherein the first and secondgluteal implants comprise a body having one of a truncated ovoid shape,a truncated approximate ovoid shape, a truncated ellipsoid shape, and atruncated approximate ellipsoid shape, wherein a ratio between a firstradius of curvature of the first and second gluteal implants and asecond radius of curvature of the first and second gluteal implants isin a range from about 0.3 to about 6.0, wherein the shape of the body ofthe first and second gluteal implants is configured to have rotationalsymmetry that conceals the effects of post-operative movement, whereinthe shape of the body of the first and second gluteal implants isconfigured to resist a post-operative movement away from an equilibriumposition and to facilitate movement toward an equilibrium positionfollowing a post-operative movement away from an equilibrium position,wherein post-operative movement includes mal-translation or mal-rotationof the body, and wherein the body of each of the first and secondgluteal implants comprises a unitary piece of material.
 12. The glutealimplant system of claim 11, wherein the body of the first and secondgluteal implants comprises a truncated approximate ovoid shape.
 13. Thegluteal implant system of claim 11, wherein the body of the first andsecond gluteal implants comprises a truncated ellipsoid shape.
 14. Thegluteal implant system of claim 11, wherein the first surface is convexand the second surface is concave.
 15. The gluteal implant system ofclaim 11, wherein the first and second gluteal implants are not“tear-drop” shaped.
 16. The gluteal implant system of claim 11, whereinthe shape of the body of the first and second gluteal implants isconfigured to resist a post-operative movement away from an equilibriumposition and to facilitate movement toward an equilibrium positionfollowing a post-operative movement away from an equilibrium position,wherein post-operative movement includes mal-translation or mal-rotationof the body.
 17. A gluteal implant comprising: a body comprising: aconvex upper surface; a concave lower surface; and a peripheral edge,the edge defined by the intersection between the convex upper surfaceand the concave lower surface, wherein the body is symmetrical acrosstwo orthogonal reference planes and comprises one of a truncated ovoidshape, a truncated approximate ovoid shape, a truncated ellipsoid shape,and a truncated approximate ellipsoid shape, wherein the convex uppersurface comprises one of a portion of a first surface selected from thegroup consisting of: an ovoid surface, an approximate ovoid surface, anellipsoid surface, and an approximate ellipsoid surface, said firstsurface having a first semi-major axis and a first radius of curvatureand a first semi-minor axis and a second radius of curvature, whereinthe concave lower surface comprises one of a portion of a second surfaceselected from the group consisting of: an ovoid surface, an approximateovoid surface, an ellipsoid surface, and an approximate ellipsoidsurface, said second surface having a second semi-major axis and a thirdradius of curvature and a second semi-minor axis and a fourth radius ofcurvature, wherein the first radius of curvature differs from the thirdradius of curvature, wherein the difference is between about 2.22 cm andabout 2.62 cm, wherein the second radius of curvature differs from thefourth radius of curvature, wherein the difference is between about 2.72cm and about 3.12 cm, wherein the convex upper surface and the concavelower surface intersect at an angle ranging from about 15 degrees toabout 40 degrees, wherein the convex upper surface forms a peak of theimplant, wherein the concave lower surface forms a peak of a concavity,wherein the edge forms a bottommost point of the implant, wherein theedge outlines an oval or ellipse when viewed from above, wherein theshape of the body is configured to have rotational symmetry thatconceals the effects of post-operative movement, wherein the shape ofthe body is configured to facilitate movement toward an equilibriumposition following post-operative movement away from an equilibriumposition, wherein post-operative movement includes mal-translation ormal-rotation, wherein the body comprises a unitary piece of material,and wherein the concave upper surface and concave lower surface aresmooth surfaces.